Nasolabial Fold CorrectionNCT07343141
To Evaluate the Safety and Efficacy of Poly-L-lactic Acid Implants for the Correction of Nasolabial Folds
A study testing FUYANMEI Poly-L-Lactic Acid and Sculptra® in people with Nasolabial Fold Correction, run by SciVision Biotech Inc. at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to evaluate the safety and effectiveness of a poly-L-lactic acid (PLLA) dermal implant for the correction of nasolabial folds. The study also aims to determine whether the investigational product (FUYANMEI Poly-L-Lactic Acid) is non-inferior to the control product (Sculptra). Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Nasolabial Fold Correction
- What is being tested?
- FUYANMEI Poly-L-Lactic Acid and Sculptra®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent prior to any study-specific procedures.
- Male or female subjects aged between 19 and 65 years.
- Presence of bilateral nasolabial fold wrinkles with a Wrinkle Severity Rating Scale (WSRS) score of moderate (Grade 3) or severe (Grade 4) at baseline.
- Willingness and ability to comply with all protocol-required follow-up visits and procedures.
Who cannot join
- History of hypertrophic scarring or keloid formation.
- Presence of active infection or dermatologic conditions at or near the intended injection site that may interfere with the evaluation.
- Underwent major surgery within 3 months prior to study initiation.
- Diagnosed with autoimmune diseases, malignancies, psychiatric disorders, or poorly controlled chronic medical conditions.
- Prior treatment with or planned use of permanent dermal fillers at the intended injection site.
- Prior treatment with or planned use of temporary fillers, collagen stimulators, or thread lifting at the injection site within 12 months prior to screening or during the study period.
Show all 13Show fewer
- Underwent or plans to undergo laser treatments to the mid- or lower face within 3 months prior to treatment or during the study period.
- Underwent or plans to undergo ultrasound or radiofrequency skin tightening procedures to the mid- or lower face within 6 months prior to treatment or during the study period.
- Known hypersensitivity to poly-L-lactic acid or any components of the investigational device, or any other significant allergy as deemed by the investigator to pose risk to the subject.
- Planned surgeries or medications during the study period that may cause significant weight changes.
- Pregnant or breastfeeding women, or women intending to become pregnant during the study period.
- Participation in another interventional clinical trial that has not concluded within 30 days prior to screening, or plans to participate in another interventional clinical study during the course of this study.
- Any other condition or situation that, in the opinion of the investigator, renders the subject unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833401
Lai-San Wong, M.D., +886-7-7317123 ext. 2424, laisan7@hotmail.com
Lai-San Wong, M.D.
About this study
Official title: A Prospective, Randomized, Evaluator/Subject-blinded, Single-center, Split-Face Controlled Clinical Study: To Evaluate the Safety and Efficacy of Poly-L-lactic Acid Implants for the Correction of Nasolabial Folds
The goal of this clinical trial is to evaluate the safety and effectiveness of a poly-L-lactic acid (PLLA) dermal implant for the correction of nasolabial folds. The study also aims to determine whether the investigational product (FUYANMEI Poly-L-Lactic Acid) is non-inferior to the control product (Sculptra).
The main questions it aims to answer are:
Read more
- Is the effectiveness rate based on the Wrinkle Severity Rating Scale (WSRS) at 6 months after injection for the investigational group non-inferior to that of the control group?
- How does the investigational product perform in terms of global aesthetic improvement as assessed by blinded evaluators and by subjects?
- What is the safety profile of the investigational product, including the incidence, severity, and relatedness of adverse events (AEs), serious adverse events (SAEs), and device deficiencies (DDs)?
Researchers will compare the investigational PLLA implant to an approved PLLA implant using a prospective, randomized, evaluator- and subject-blinded, single-center, split-face controlled study design. Approximately 121 eligible participants will be enrolled.
Participants will:
- Receive treatment with the investigational product and the control product according to the split-face design
- Be followed for 24 months after injection
- Return to the clinic at 1, 3, 6, 12, 18, and 24 months post-injection for follow-up visits
- Undergo blinded evaluator assessments of WSRS and Global Aesthetic Improvement Scale (GAIS)
- Complete subject self-assessments of GAIS and treatment satisfaction
- Be monitored throughout the study for adverse events, serious adverse events, and medical device deficiencies
- Conditions
- Nasolabial Fold Correction
- Being tested
- FUYANMEI Poly-L-Lactic Acid, Sculptra®
- Keywords
- Poly-L-lactic Acid, Nasolabial folds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FUYANMEI Poly-L-Lactic AcidDevice
Poly-L-Lactic Acid
Sculptra®Device
Poly-L-Lactic Acid
| Study group | Role | What they receive |
|---|---|---|
| FUYANMEI Poly-L-Lactic Acid | Experimental | Poly-L-Lactic Acid Receives: Device: FUYANMEI Poly-L-Lactic Acid |
| Sculptra® | Active comparator | Poly-L-Lactic Acid Receives: Device: Sculptra® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The responder rate based on the Wrinkle Severity Rating Scale (WSRS).
The WSRS responder rate at Month 6 post-injection was compared between the treatment and control groups. A WSRS responder was defined as a participant who achieved an improvement of at least 1 point in the WSRS score compared with baseline.
Measured: at Month 6 post-injection
Secondary outcomes (8)
Wrinkle Severity Rating Scale (WSRS) scores
WSRS was assessed using a 5-point scale (1-5), with higher scores indicating greater wrinkle severity. Blinded evaluators assessed WSRS scores at baseline, immediately post-treatment (Day 0), and at Months 1, 3, 6, 12, 18, and 24 following injection.
Measured: at baseline, immediately post-treatment (Day 0), and at Months 1, 3, 6, 12, 18, and 24 post-injection
WSRS responder rates
WSRS responder rates assessed by blinded evaluators at baseline, Day 0, and Months 1, 3, 12, 18, and 24 post-injection. A WSRS responder was defined as a participant who achieved an improvement of at least 1 point in the WSRS score compared with baseline.
Measured: at baseline, Day 0, and Months 1, 3, 12, 18, and 24 post-injection
Change in nasolabial fold volume
Images were captured using a VECTRA H2 3D camera (Canfield Scientific) at a fixed distance from the subject's face under standardized lighting and background conditions. The resulting image files were analyzed for volumetric measurements using 3D imaging software. Changes in nasolabial fold volume from baseline (Day 0) were assessed at Months 1, 3, 6, 12, 18, and 24 using the three-dimensional imaging system.
Measured: at baseline, Day 0, and Months 1, 3, 6, 12, 18, and 24 post-injection
Global Aesthetic Improvement Scale (GAIS) scores
GAIS scores were measured using a 5-point scale (1-5), with lower scores indicating poorer improvement. Blinded evaluators assessed GAIS scores immediately post-treatment (Day 0) and at Months 1, 3, 6, 12, 18, and 24 after injection.
Measured: at immediately post-treatment (Day 0), and Months 1, 3, 6, 12, 18, and 24 post-injection
Subject-reported GAIS scores
Subject-reported GAIS scores at immediately post-treatment (Day 0), and Months 1, 3, 6, 12, 18, and 24 post-injection.
Measured: at immediately post-treatment (Day 0), and Months 1, 3, 6, 12, 18, and 24 post-injection
Subject-reported satisfaction scores
Subject-reported satisfaction was assessed at Months 1, 3, 6, 12, 18, and 24 post-injection. Participants rated their satisfaction with the treatment's safety and effectiveness using a questionnaire scored on a 5-point scale (1-5), where 5 indicated very high satisfaction and 1 indicated very low satisfaction.
Measured: at Months 1, 3, 6, 12, 18, and 24 post-injection
Incidence of Adverse Events (AEs)
The incidence rate of adverse events (AEs), expressed as a percentage, will be calculated based on subjects who reported AEs or whose AEs were observed by investigators. The incidence rate will be determined using the following formula: AE (%) = (number of subjects who experienced AEs in each group ÷ total number of subjects in each group) × 100. Adverse events will be assessed on the day of treatment and at Months 1, 3, 6, 12, 18, and 24 post-treatment.
Measured: at Day 0, Months 1, 3, 6, 12, 18, and 24 post-injection
Incidence of Serious Adverse Events (SAEs)
The incidence rate of serious adverse events (SAEs), expressed as a percentage, will be calculated based on subjects who reported SAEs or whose SAEs were observed by investigators. The incidence rate will be determined using the following formula: SAE (%) = (number of subjects who experienced SAEs in each group ÷ total number of subjects in each group) × 100. Adverse events will be assessed on the day of treatment and at Months 1, 3, 6, 12, 18, and 24 post-treatment.
Measured: at Day 0, Months 1, 3, 6, 12, 18, and 24 post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jun 2026 (estimated)
- Primary completion28 Jun 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial Fold CorrectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SciVision Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343141
- Sponsor's protocol ID
- RDCT-NFFU
- Status last verified
- May 2026
- First submitted
- 6 Jan 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Evaluator/Subject-blinded, Single-center, Split-Face Controlled Clinical Study: To Evaluate the Safety and Efficacy of Poly-L-lactic Acid Implants for the Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT07343141
- Acronym / sponsor ID
- RDCT-NFFU
- Conditions
- Nasolabial Fold Correction
- Keywords
- Poly-L-lactic Acid, Nasolabial folds
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- SciVision Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 28 Jun 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the safety and effectiveness of a poly-L-lactic acid (PLLA) dermal implant for the correction of nasolabial folds. The study also aims to determine whether the investigational product (FUYANMEI Poly-L-Lactic Acid) is non-inferior to the control product (Sculptra).
The main questions it aims to answer are:
- Is the effectiveness rate based on the Wrinkle Severity Rating Scale (WSRS) at 6 months after injection for the investigational group non-inferior to that of the control group?
- How does the investigational product perform in terms of global aesthetic improvement as assessed by blinded evaluators and by subjects?
- What is the safety profile of the investigational product, including the incidence, severity, and relatedness of adverse events (AEs), serious adverse events (SAEs), and device deficiencies (DDs)?
Researchers will compare the investigational PLLA implant to an approved PLLA implant using a prospective, randomized, evaluator- and subject-blinded, single-center, split-face controlled study design. Approximately 121 eligible participants will be enrolled.
Participants will:
- Receive treatment with the investigational product and the control product according to the split-face design
- Be followed for 24 months after injection
- Return to the clinic at 1, 3, 6, 12, 18, and 24 months post-injection for follow-up visits
- Undergo blinded evaluator assessments of WSRS and Global Aesthetic Improvement Scale (GAIS)
- Complete subject self-assessments of GAIS and treatment satisfaction
- Be monitored throughout the study for adverse events, serious adverse events, and medical device deficiencies
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FUYANMEI Poly-L-Lactic Acid | Experimental | Device: FUYANMEI Poly-L-Lactic AcidPoly-L-Lactic Acid |
| Sculptra® | Active comparator | Device: Sculptra®Poly-L-Lactic Acid |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing and able to provide written informed consent prior to any study-specific procedures.
- Male or female subjects aged between 19 and 65 years.
- Presence of bilateral nasolabial fold wrinkles with a Wrinkle Severity Rating Scale (WSRS) score of moderate (Grade 3) or severe (Grade 4) at baseline.
- Willingness and ability to comply with all protocol-required follow-up visits and procedures.
Key exclusion criteria (13 listed)
- History of hypertrophic scarring or keloid formation.
- Presence of active infection or dermatologic conditions at or near the intended injection site that may interfere with the evaluation.
- Underwent major surgery within 3 months prior to study initiation.
- Diagnosed with autoimmune diseases, malignancies, psychiatric disorders, or poorly controlled chronic medical conditions.
- Prior treatment with or planned use of permanent dermal fillers at the intended injection site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FUYANMEI Poly-L-Lactic AcidPoly-L-Lactic Acid | Device | FUYANMEI Poly-L-Lactic Acid |
| Sculptra®Poly-L-Lactic Acid | Device | Sculptra® |
Primary outcome
The responder rate based on the Wrinkle Severity Rating Scale (WSRS).
Time frame: at Month 6 post-injection
The WSRS responder rate at Month 6 post-injection was compared between the treatment and control groups. A WSRS responder was defined as a participant who achieved an improvement of at least 1 point in the WSRS score compared with baseline.
8 secondary outcomes
Wrinkle Severity Rating Scale (WSRS) scores
Time frame: at baseline, immediately post-treatment (Day 0), and at Months 1, 3, 6, 12, 18, and 24 post-injection
WSRS responder rates
Time frame: at baseline, Day 0, and Months 1, 3, 12, 18, and 24 post-injection
Change in nasolabial fold volume
Time frame: at baseline, Day 0, and Months 1, 3, 6, 12, 18, and 24 post-injection
Global Aesthetic Improvement Scale (GAIS) scores
Time frame: at immediately post-treatment (Day 0), and Months 1, 3, 6, 12, 18, and 24 post-injection
Subject-reported GAIS scores
Time frame: at immediately post-treatment (Day 0), and Months 1, 3, 6, 12, 18, and 24 post-injection
Subject-reported satisfaction scores
Time frame: at Months 1, 3, 6, 12, 18, and 24 post-injection
Incidence of Adverse Events (AEs)
Time frame: at Day 0, Months 1, 3, 6, 12, 18, and 24 post-injection
Incidence of Serious Adverse Events (SAEs)
Time frame: at Day 0, Months 1, 3, 6, 12, 18, and 24 post-injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FUYANMEI Poly-L-Lactic Acid and Sculptra® in people with Nasolabial Fold Correction, run by SciVision Biotech Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lai-San Wong, M.D. (+886-7-7317123 ext. 2424, laisan7@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The responder rate based on the Wrinkle Severity Rating Scale (WSRS). (time frame: at Month 6 post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.